Z-0938-2026Class III

HemosIL SynthAFax. Partial Thromboplastin Time Tests

Name: Z-0938-2026 HemosIL SynthAFax. Partial Thromboplastin Time Tests
Creator: Instrumentation Laboratory
Published: 2025-11-18
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2025-11-18 / Open, Classified / root cause: manufacturing process

FDA source

Instrumentation Laboratory began a recall of HemosIL SynthAFax. Partial Thromboplastin Time Tests on 2025-11-18. FDA classified it as Class III and gives the reason as "Recalled lots were manufactured with double the amount of preservative concentration". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0938-2026
Classification: Class III
Status: Open, Classified
Initiated: 2025-11-18
Posted: 2025-12-17
Recalling firm: Instrumentation Laboratory Co.
Product: HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Product code: GFO Activated Partial Thromboplastin
Reason for recall: Recalled lots were manufactured with double the amount of preservative concentration.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 4,506 units
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 codes and lots: Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0938-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0938-2026	Class III	Ongoing	Voluntary: Firm initiated	2025-12-24	2025-12-17

Product code GFO

K955638Class IISynthafax Aptt ReagentOrtho Diagnostic Systems, Inc. / cleared 1996-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)