Recall Z-2771-2020 ยท QKO Reagent, Coronavirus Serological
Ortho Clinical Diagnostics
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
| Date | Jul 17, 2020 |
| Status | Terminated |
| Reason | The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures. |
| Root cause | Process control |
| Action | On July 17, 2020, the firm issued Urgent Product Correction Notification letters to affected customers. Customers were informed of the potential for erroneous patient sample results, calibration errors, and QC failures when using the impacted product. Customers were asked to do the following; " Visually inspect affected VITROS Anti-SARS-CoV-2 Total (Lots 0010-0037) and IgG (Lots 0010-0013) Reagent Packs to ensure correct reagent bottle configuration " Set aside any pack in which the reagent bottles are positioned incorrectly, so the lot number and pack id can be provided to Ortho. Complete |
| Quantity | 2349 sales units |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.