Beckman Coulter Inc. recalls AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
Lipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive bias up to 30.38% in low magnesium patient samples. The impact is…
Read the official notice →- Date
- 2022-03-09
- Country
- United States
- Brand
- Beckman Coulter
- Product
- AU/DxC AU Magnesium, Catalog/REF Number OSR6189, UDI 15099590010850
- Classification
- Class II
- Units
- US: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Beckman Coulter recalls
- 2022-11-30
USBeckman Coulter, Inc. recalls MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
FDA · DeviceBeckman Coulter, Inc.Worldwide - U.S. Nationwide distribution in the states of AK, FL, IA, ID, MI…Official notice →- 2022-05-25
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Beckman Coulter Inc. recalls MicroScan WalkAway-40 plus Instrument REF B1018-283
WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere
FDA · DeviceBeckman Coulter Inc.Worldwide distribution - U.S. Nationwide distribution in the states of Alaska,…Official notice → - 2022-04-27
- US
Beckman Coulter, Inc. recalls Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.
IRISpec CA failures for glucose.
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide, including Puerto Rico and the…Official notice → - 2021-12-29
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Beckman Coulter Inc. recalls SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in…
FDA · DeviceBeckman Coulter Inc.US Nationwide distribution in the states of Louisiana, Ohio, North Carolina,…Official notice → - 2021-10-20
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Beckman Coulter Inc. recalls Power Processor 3K, 3K High Speed Stockyards Module Nameplate: PP 3K Stockyard (Refrig) 9707 REF A88116
Missing splash guard which may expose users to hazardous materials. .
FDA · DeviceBeckman Coulter Inc.U.S. Nationwide Distribution in the states of: CA, GA, IA, ID, IL, IN, LA, MA,…Official notice → - 2021-10-13
- US
Beckman Coulter Inc. recalls Access hsTnI High Sensitivity Troponin I, REF B52699 Access Immunoassay System REAGENT PACK
Through customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent pack. The carryover is caused by sample-to-pack carryover…
FDA · DeviceBeckman Coulter Inc.U.S.: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, Guam, HI, IA, ID, IL, IN, KS,…Official notice →
Other drugs & medical recalls in the United States
- 2022-03-09
- US
Microbiologics Inc recalls Microbiologics QC Sets and Panels: Helix Elite. Extended Enteric Bacterial Verification Panel (Inactivated Pellet) includes 21 pellets…
Real-time shelf life testing failed at 24 months
FDA · DeviceMicrobiologics IncWorldwide distribution - US Nationwide distribution in the states of AK, CA,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes
Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of Panama and Bermuda.Official notice → - US
ROi CPS LLC recalls Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
Products are mislabeled with the incorrect product identification on individual kit labeling.
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BioPro, Inc. recalls Titanium MPJ (Toe Implant) TOE JOINT TITANIUM PC M/L, Part ID 17037
There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been…
FDA · DeviceBioPro, Inc.US Nationwide distribution in the states of CT, KY, NM, PA, TN, and SD.Official notice → - US
Acorn Stairlifts, Inc recalls Acorn 130 Stairlift, Brooks 130 Stairlift, Acorn 180 Stairlift, and Acorn Outdoor Stairlift
The design of the seats did not consistently have the adequate strength required to support the customers weight with continued use.
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CELLTRION USA INC recalls Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
Returned test kits were erroneously shipped to customers. The kits are intended for Research Use Only (RUO). Additional RUO test kits were shipped to customers unlikely to use them for RUO purposes, and the firm…