Abbott Laboratories recalls Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01.…
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Read the official notice →- Date
- 2023-12-27
- Country
- United States
- Brand
- Abbott Laboratories
- Product
- Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01.…
- Classification
- Class II
- Units
- Distribution was made to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Abbott Laboratories recalls
- 2024-04-10
USAbbott Laboratories recalls ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis…
FDA · DeviceAbbott LaboratoriesWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL,…Official notice →- 2024-01-17
- US
Abbott Laboratories recalls Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and…
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
FDA · DeviceAbbott LaboratoriesU.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,…Official notice → - 2024-01-03
- US
Abbott Laboratories recalls Alinity ci-series System Control Module, REF: 03R70-01
There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3)…
FDA · DeviceAbbott LaboratoriesUS: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,…Official notice → - 2023-11-15
- US
Abbott Laboratories recalls Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
FDA · FoodAbbott LaboratoriesAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida,…Official notice → - 2023-04-19
- US
Abbott Laboratories recalls Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
Potential of foreign material (hard plastic) within product
FDA · FoodAbbott LaboratoriesAL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO,…Official notice → - 2023-01-25
- US
Abbott Laboratories recalls Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Reaction vessels may contain a potential contaminant that could affect their optical performance.
FDA · DeviceAbbott LaboratoriesUS Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WVOfficial notice →
Other drugs & medical recalls in the United States
- 2023-12-27
- US
Stryker Spine recalls LITe Decompression Snake Arm, REF 48080230
Product arm was manufactured with the incorrect clamp component. As a result, the affected product arm cannot attach to the arm post shaft.
- US
Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to…
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of…
FDA · DeviceSiemens Healthcare Diagnostics IncNationwide with Worldwide Distribution to: Albania Algeria Angola Argentina…Official notice → - US
Maquet Medical Systems USA recalls Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Firm received complaints of breaks in the insulation, shielding, or wires of the venous probe connection cable. Fracture of the venous probe cable may influence the management of extracorporeal support. Patient may be…
FDA · DeviceMaquet Medical Systems USADomestic distribution Nationwide. Foreign distribution to Argentina,…Official notice → - US
Zeus Scientific, Inc. recalls ZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701G
The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.
- US
Siemens Healthcare Diagnostics Inc recalls epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX),…
Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS…
- US
Maquet Medical Systems USA recalls CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the…
CARDIOHELP-i System was not properly tested to measure leakage current
FDA · DeviceMaquet Medical Systems USANationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan,…Official notice →