Recall Z-2976-2026
Siemens Healthcare Diagnostics, Inc. · initiated July 13, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Codes / lots: Lots: 2597, 2627, 2709/UDI: 00842768023293
Reason for recall
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.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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 may have received this product.
Details
- Recall number
- Z-2976-2026
- Initiated
- July 13, 2026
- Posted by FDA
- August 17, 2026
- Product code
- LBZ – Enzyme Immunoassay, Quinidine
- Quantity
- 55 units
- Distribution
- Worldwide - US Nationwide distribution in the state of CA and the country of Italy.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., East Walpole, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2975-2026 Class II | Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mLDue to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which… | 07/13/2026Open, Classified |