Recall Z-0938-2026— Instrumentation Laboratory

Name: FDA recall Z-0938-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-18

Class III · Ongoing

Class III FDA medical device recall by Instrumentation Laboratory, initiated 2025-11-18. It names one FDA 510(k) clearance: K955638. Product: HemosIL SynthAFax. Partial Thromboplastin Time Tests.. Reason: Recalled lots were manufactured with double the amount of preservative concentration..

Recalling firm: Instrumentation Laboratory
Classification: Class III
Status: Ongoing
Initiated: 2025-11-18
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K955638 — SYNTHAFAX APTT REAGENTOrtho Diagnostic Systems, Inc.·cleared 1996-04-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Reason for recall

Recalled lots were manufactured with double the amount of preservative concentration.

Data sourced from openFDA. This site is unofficial and independent of the FDA.