HemosIL SynthAFax. Partial Thromboplastin Time Tests recallZ-0938-2026 · Instrumentation Laboratory · initiated Nov 18, 2025
Open, Classified
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 Instrumentation Laboratory 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
Recalled lots were manufactured with double the amount of preservative concentration.
FDA root cause category: Process control
What the company is doing
An URGENT MEDICAL DEVICE RECALL notification, dated 11/18/25, was sent to consignees. Consignees are to contact Client Services at 1-800-955-9525 to arrange conversion to replacement lot N0956748, and in the meantime continue use of affected lots with the QC lot reassignments provided and run QC per labeled instructions for use. Once the replacement lot is received, consignees are to complete the cross-over study per laboratory procedures and immediately destroy affected devices, documenting destruction on the provided Mandatory Urgent Medical Device Recall Tracking Form which should be returned to WERFEN by fax at 781-861-4207 or by email to [email protected]. All laboratory staff are to be notified of this recall and a copy of the notice posted near IL Coagulation Systems. Consignees with any questions are to contact Client Services at 1-800-955-9525.
Recall details
- Recall number
- Z-0938-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 18, 2025
- Posted by the FDA
- Dec 17, 2025
- Recalling firm
- Instrumentation Laboratory
- Quantity
- 4,506 units
- Product code
- GFO
- FDA submissions
- K955638
- Distribution
- Domestic: CA, CO, FL, NY; Foreign: AR, AT, CA, CZ, DE, DK, ES, FR, GB, IE, IL, IN, IT, JP, LK, NL, PL, PT, RO, RS, TH, VN.
Product description
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Code information (models, lots, serial numbers)
Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HemosIL SynthAFax 00020007400Instrumentation Laboratory Company · ACTIVATED PARTIAL THROMBOPLASTIN1 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 16, 2026. Text above is shown as published by the FDA.
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