Beckman Coulter Inc.: ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.

Is my product affected?

ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.

• UPC 15099590738662

Check against the official notice below — it lists the full affected range.

What happened

Beckman Coulter Inc. is recalling 276 units of ACCESS SARS-CoV-2 IgG Quality Control cards (Catalog Number C58964, Lot Number 922407) used with the Access Family of Immunoassay Systems. The cards contain a label error affecting the standard deviation values printed on one of the two quality control levels. The affected products were distributed worldwide, including across numerous U.S. states and territories as well as 17 other countries including Canada, Mexico, and several European nations.

The source document does not specify a remedy or what affected consumers should do in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.

Details from the source

Reason for recall: The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC. Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS,KY, LA, MD, MI, MN, MO, NC, ND, NY, OH, OK, OR, PA, Puerto Rico, SD, TX, WA, and WV. The countries of Andorra, Belgium, Brazil, Bulgaria, Canada*, Croatia, France, Germany, Hong Kong, Italy, Jordan, Mexico, Paraguay, Poland, Portugal, Romania, Spain, and United Kingdom. Quantity: 276 units Lot/code info: Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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