Recall Z-2976-2026 ยท LBZ Enzyme Immunoassay, Quinidine
Siemens Healthcare Diagnostics, Inc.
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
| Date | Aug 17, 2026 (initiated Jul 13, 2026) |
| Status | Open, Classified |
| Reason | Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy. |
| Root cause | Unknown/Undetermined by firm |
| Action | On July 14, 2026, Simens Healthineers issued a Urgent Medical Device Correction notification via FedEx. Simens asked consignees to take the following actions: 1. Review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 2. Discontinue use of and discard the kit lots listed in the Products Section. 3. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 4. Retain this letter with your laboratory records and forward this letter to those who ma |
| Quantity | 55 units |
| Distribution | Worldwide - US Nationwide distribution in the state of CA and the country of Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011605 | EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 Syva Co., Dade Behring, Inc., Jun 12, 2001 |