Alere San Diego, Inc. recalls Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell which could cause minor burns, cuts or abrasions, or low…
Read the official notice →- Date
- 2024-05-08
- Country
- United States
- Brand
- Alere San Diego
- Product
- Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of United Kingdom,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Alere San Diego recalls
- 2026-10-07
US
Alere San Diego, Inc. recalls Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/…
hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.
FDA · DeviceAlere San Diego, Inc.Worldwide - US Nationwide distribution including in the states of IL, PA, FL,…Official notice →- 2022-08-17
US
Alere San Diego, Inc. recalls The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol,…
Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or…
FDA · DeviceAlere San Diego, Inc.US: IL, NV, FL, LA, CA, MA, MN, NC, AK, NE, TX, PA, RI, SC, TN, OK, KY, GA,…Official notice →
Other drugs & medical recalls in the United States
- 2024-05-08
US
Covidien recalls Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
FDA · DeviceCovidienUS: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI…Official notice →US
Zimmer, Inc. recalls ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile- Indicated for temporary…
Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock,…
FDA · DeviceZimmer, Inc.Worldwide distribution - US Nationwide and the countries of Brazil, Canada,…Official notice →US
IVOCLAR VIVADENT AG recalls IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and…
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
US
Olympus Corporation of the Americas recalls POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery and such…
Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no energy would be delivered to…
FDA · DeviceOlympus Corporation of the AmericasWorldwide distribution - US Nationwide and the countries of AU, CA, HK, KR.Official notice →US
Advanced Research Medical, LLC recalls ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4; treatment of…
Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery.
FDA · DeviceAdvanced Research Medical, LLCUS Nationwide distribution in the state of Minnesota.Official notice →US
Covidien, LP recalls Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile, non-mutagenic surgical suture composed of natural silk…
One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. This may decrease the tensile strength of the sutures over time, which could result in harms such as wound…
FDA · DeviceCovidien, LPInternational distribution in the countries of Portugal and Italy.Official notice →