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…
Read the official notice →- Date
- 2021-12-29
- Country
- United States
- Brand
- Beckman Coulter
- Product
- SYNCHRON Systems Cholesterol (CHOL) Reagent, REF: 467825
- Classification
- Class II
- Units
- US Nationwide distribution in the states of Louisiana, Ohio, North Carolina,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-05-25
USBeckman 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
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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 → - 2022-03-09
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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…
FDA · DeviceBeckman Coulter Inc.US: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut,…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
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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 → - 2021-10-06
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Beckman Coulter Inc. recalls DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped…
FDA · DeviceBeckman Coulter Inc.US Nationwide distribution in the states of AL, CA, IL, In, KY, MN, MI, OH,…Official notice →
Other drugs & medical recalls in the United States
- 2021-12-29
- US
Hill-Rom Inc. recalls These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0…
An unrecoverable error may occur where a component will fail to complete the reboot cycle, become non-functional and must be replaced.
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Wright Medical Technology, Inc. recalls Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc…
Incorrect product is contained in the packaging.
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Stradis Medical, LLC dba Stradis Healthcare recalls Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.
FDA · DeviceStradis Medical, LLC dba Stradis HealthcareNJ, MI, MA, NY, TX, CO, NC, CT, OR, OHOfficial notice → - US
Civco Medical Instruments Co. Inc. recalls VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
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Cardiovascular Systems Inc recalls WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Catheter, 6Fr, REF (Model Number) WRN-D6
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Wright Medical Technology Inc recalls Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
The incorrect product is contained in the packaging.
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