ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A recallZ-2171-2026 · Aniara Diagnostica LLC · initiated Apr 1, 2026
Class II Open, Classified All recalls posted in May 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aniara Diagnostica LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.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 root cause category: Labeling Change Control
What the company is doing
A 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 The outdated flyer included in the kit must be immediately removed and destroyed, as well as any paper or electronic copy that could have been done in end-user facility, to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 [email protected].
Recall details
- Recall number
- Z-2171-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Apr 1, 2026
- Posted by the FDA
- May 12, 2026
- Recalling firm
- Aniara Diagnostica LLC
- Quantity
- 359 units
- Product code
- LCO
- FDA submissions
- K071255
- Distribution
- US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
Product description
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Code information (models, lots, serial numbers)
UDI-DI: 03663537018763; Lot Number: FD1265
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ZYMUTEST HIA IgG RK040AHyphen Biomed · Platelet Factor 4 Radioimmunoassay1 recall0 reports
Other devices under the same FDA submission
2 devices cleared under K071255 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ZYMUTEST HIA IgGAM RK040DHyphen Biomed · Platelet Factor 4 Radioimmunoassay1 recall0 reports
- ZYMUTEST HIA MonoStrip IgGAM RK041DHyphen Biomed · Platelet Factor 4 Radioimmunoassay1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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