Recall Z-2488-2023 · CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Beckman Coulter Inc.
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
| Date | Aug 31, 2023 (initiated Jul 12, 2023) |
| Status | Open, Classified |
| Reason | Lipemic interference failed to meet the performance specification listed within the IFU. |
| Root cause | Other |
| Action | On July 18, 2023 Beckman Coulter issued a "Urgent Medical Device Recall" Notification via email and postal mail. Beckman Coulter asked consignees to take the following action: 1. No retrospective re view of past patient results is required however Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. 2. Discontinuance or disposal of this product is not necessary. 3. Per the IFU, avoid highly lipemic samples when using the IgA assay. 4. No update is required to the LIH influe |
| Quantity | 12,850 units |
| Distribution | US: AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD MI MN MO MS NC ND NE NJ NM NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV OUS: Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, C¿te d'Ivoire, Croatia, Cur |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073489 | OLYMPUS IGA REAGENT Olympus America, Inc., Feb 11, 2008 |