Recall Z-0749-2022 ยท MZA Test, Equipment, Automated Bloodborne Pathogen
Abbott Laboratories, Inc
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.
| Date | Feb 3, 2022 |
| Status | Open, Classified |
| Reason | Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe. |
| Root cause | Under Investigation by firm |
| Action | On February 3, 2022, Abbott issued two "Urgent Product Correction" notifications. For US customers these notification where delivered by Abbott personnel. For OUS consignees letters were provided by Abbott personnel or by email. During the week of February 25, 2022, an updated letter was provided to US customers containing additional information. In addition to informing consignees about the recall the firm provided the following instructions Please perform the necessary immediate actions, if utilizing the Alinity s HIV Ag/Ab Combo and Alinity s Anti-HCV II assays while operating on Alinity |
| Quantity | 306 units |
| Distribution | Worldwide distribution: US (nationwide) including states of: AL, CA, GA, IL, IN, MN, MO, NC, OK, PA, RI, SC, TN, TX, WA, WI, MD and countries (OUS) including of: Australia, Austria, Bahrain, Belgium, Brazil, china, Colombia, Croatia, Cyprus, Czech Republic, Egypt, Germany, Greece, Hong Kong, Hungary |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.