Recall Z-1377-2023 ยท NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Bio-Rad Laboratories, Inc.
BioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD
| Date | Apr 12, 2023 (initiated Feb 21, 2023) |
| Status | Open, Classified |
| Reason | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives. |
| Root cause | Under Investigation by firm |
| Action | On February 21, 2023, Bio-Rad Laboratories issued a "Urgent: Medical Device Recall" notification to affected consignees. In addition to informing consignees about the recall, Bio-Rad asked consignees to take the following actions: 1. We are requesting that customers discontinue the use of and dispose of according to local waste management procedures any unused BioPlex 2200 Anti-CCP Reagent Pack (Catalog No. 665-3250, UDI GTIN 00847865000857) Lot No. 301481 and BioPlex 2200 Anti-CCPCalibrator Set (Catalog No. 663-3200, UDI GTIN 00847865000819) Lot No. 53727. 2. If you have distributed or tra |
| Quantity | 1544 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Czech Republic, Germany, Spain, France, United Kingdom, Israel, Italy, Norway, Sweden. |
| FDA record | Open on fda.gov |