Recall Z-0207-2027 ยท OHQ Multi-Analyte Controls Unassayed
TECHNO-PATH MANUFACTURING LTD.
Techno-Path Multichem AE Unassayed Level 3, REF:AE623X
| Date | Oct 22, 2026 (initiated Aug 14, 2026) |
| Status | Open, Classified |
| Reason | A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision |
| Root cause | Under Investigation by firm |
| Action | On August 14, 2026, Techno Path Manufacturing Ltd has issued a medical device correction to consignees via email. Techno Path Manufacturing Ltd informed consignees to please verify their inventory against the affected product codes and lot numbers. Techno Path Manufacturing Ltd. has informed the consignees to take the following actions: 1. Immediately place all affected inventory on hold and prevent further distribution. 2. Quarantine all affected product currently under your control. 3. Confirm that there has been no distribution of the impacted lots to customers. 4. Confirm receipt of this |
| Quantity | 832 units |
| Distribution | US Nationwide distribution in the state of Massachusetts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.