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U.S. Department of Health and Human Services

Class 2 Device Recall TechnoPath Multichem AE Unassayed Level 3

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 Class 2 Device Recall TechnoPath Multichem AE Unassayed Level 3see related information
Date Initiated by FirmAugust 14, 2026
Date PostedOctober 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0207-2027
Recall Event ID 99724
Product Classification Multi-analyte controls unassayed - Product Code OHQ
ProductTechno-Path Multichem AE Unassayed Level 3, REF:AE623X
Code Information UDI:(01)05391523442824/-Lot # 65705263
FEI Number 3008156187
Recalling Firm/
Manufacturer		 TECHNO-PATH MANUFACTURING LTD.
Fort Henry Business Park
Ballina Tipperary Ireland
For Additional Information ContactBernd Hass
+353-61525700
Manufacturer Reason
for Recall		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 points.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 notification and provide inventory and distribution details to Technopath Manufacturing Ltd. within 3 business days. 5. Arrange return or destruction of affected inventory in accordance with instructions provided by Technopath Manufacturing Ltd.
Quantity in Commerce832 units
DistributionUS Nationwide distribution in the state of Massachusetts.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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