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U.S. Department of Health and Human Services

Class 2 Device Recall ZYMUTEST

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 Class 2 Device Recall ZYMUTESTsee related information
Date Initiated by FirmApril 01, 2026
Date PostedMay 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2171-2026
Recall Event ID 98754
510(K)NumberK071255 
Product Classification Platelet factor 4 radioimmunoassay - Product Code LCO
ProductZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Code Information UDI-DI: 03663537018763; Lot Number: FD1265
FEI Number 3005017664
Recalling Firm/
Manufacturer		 Aniara Diagnostica LLC
7768 Service Center Dr
West Chester OH 45069-2442
For Additional Information Contact
513-770-1993
Manufacturer Reason
for Recall		Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
FDA Determined
Cause 2		Labeling Change Control
ActionA Field Corrective Action notification letter dated 3/30/26 was sent to customers. Actions implemented by HYPHEN BioMed: -Confirmation of the existence of a flyer discrepancy affecting 95 kits from lot FD1265. - Request for quarantine of the affected kits in US agent warehouse. -Coordination with US agent for notification of the impacted end users. -investigation to define the root cause and to establish corrective and preventive actions. Actions to be implemented by the end user: 1. Check the TAV flyer included in their kit. - If the flyer matches the correct version (dated 18 October 2024) - No action is required. - If the flyer corresponds to the incorrect version (dated I October 2024) - proceed to step 2 2. Destroy the incorrect TAV flyer. The outdated flyer included in the kit must be immediately removed and destroyed, as well as any paper or electronic copy that could have been done in end-user facility, to prevent further use. 3. Replace the incorrect flyer with the corrected version. Use the corrected TAV flyer provided with this notice for all future testing 4. Return the completed and signed form to your local distributor before April 15th, 2026. For any question or information regarding this notification, please contact vigilance team, by email at VigilanceHBM@hyphen-biomed.com.
Quantity in Commerce359 units
DistributionUS Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
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.
510(K) Database510(K)s with Product Code = LCO
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