Access Sars-cov-2 Igg QC Sars-cov-2 Igg recall
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Why was Access Sars-cov-2 Igg QC Sars-cov-2 Igg recalled?
The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407
- Product
- ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 276 units
- 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.
- Recall date
- January 27, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)