Instrumentation Laboratory: Medical Device Recall in 2025 - (Recall #: Z-0938-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

HemosIL SynthAFax. Partial Thromboplastin Time Tests.

Product Classification:

Class III

Date Initiated: November 18, 2025

Date Posted: December 24, 2025

Recall Number: Z-0938-2026

Event ID: 98019

Reason for Recall:

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

Status: Ongoing

Product Quantity: 4,506 units

Code Information:

Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated