HemosIL SynthAFax Partial Thromboplastin Time Tests Recall: Double Preservative Risk
Instrumentation Laboratory recalls HemosIL SynthAFax partial thromboplastin time tests due to double preservative concentration in some lots. Affected units have specific lot numbers and expiration dates.
Lower-risk recall
Recalled lots were manufactured with double the amount of preservative concentration.
Contact the company
What happened, in plain English
Instrumentation Laboratory is recalling HemosIL SynthAFax partial thromboplastin time tests because some batches were made with double the preservative concentration. This could cause inaccurate test results or other issues if used improperly. Read more at govinfonow.com/recall/50639-hemosil-synthafax-partial-thromboplastin-time-tests-recall-double-preservative-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/50639-hemosil-synthafax-partial-thromboplastin-time-tests-recall-double-preservative-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0938-2026
Cite this page
“HemosIL SynthAFax Partial Thromboplastin Time Tests Recall: Double Preservative Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50639-hemosil-synthafax-partial-thromboplastin-time-tests-recall-double-preservative-risk. Based on FDA recall #Z-0938-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0938-2026%22&limit=1).
Why it’s dangerous
The recalled lots contain double the preservative concentration compared to what's safe. This could lead to inaccurate test results, potentially affecting blood clotting assessments. However, the risk of serious harm is low if the tests are used correctly.
Who’s affected
Healthcare professionals using the HemosIL SynthAFax for blood tests are most likely affected. Patients using these tests may be at risk if the test results are inaccurate.
How to tell if you have this one
Check the product label for lot numbers: N0542231 (expires 2026-06-30), N0250088 (expires 2027-04-30), or N0452249 (expires 2027-06-30). The product is a partial thromboplastin time test kit from Instrumentation Laboratory.
- Brand
Instrumentation Laboratory- Category
Medical device
What to do — step by step
Check Product Label
Look for lot numbers N0542231 (expires 2026-06-30), N0250088 (expires 2027-04-30), or N0452249 (expires 2027-06-30) on the HemosIL SynthAFax kit.
Where it went and when
Where it was distributed
Distributed in 4 states, and outside the U.S.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Colorado, Florida, New York.
Recall timeline
FDA published this recall 36 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0938-2026 (November 18, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0938-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.