Summary
The FDA issued a Class III for HemosIL SynthAFax. Partial Thromboplastin Time Tests. by Instrumentation Laboratory. Reason: Recalled lots were manufactured with double the amount of preservative concentration..
Details
Source
Device Recall
External ID
Z-0938-2026
Action Date
2025-12-24
Status
Ongoing
Category
device
Product Description
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Lot/Code Info: Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).
Quantity Affected: 4,506 units
Reason for Recall
Recalled lots were manufactured with double the amount of preservative concentration.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-18
Company
Bedford, MA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 208 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Instrumentation Laboratory has 39 FDA actions in our database, including 38 recalls and 1 clearance.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Instrumentation Laboratory) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Instrumentation Laboratory have FDA actions?
Instrumentation Laboratory has 39 FDA actions in our database, including 38 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0938-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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