FDA Device recall Z-0938-2026
HemosIL SynthAFax
- FDA Device
- Class III
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class III recall of HemosIL SynthAFax by Instrumentation Laboratory, citing recalled lots were manufactured with double the amount of preservative concentration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0938-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-11-18 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Instrumentation Laboratory |
| Distribution | AR, CA, CO, DE, FL, IL, IN, NY |
Product
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Reason
Recalled lots were manufactured with double the amount of preservative concentration.
Identifiers
| code_info | Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Instrumentation Laboratory
- HemoslL AcuStar HIT-lgG(PF-4)
FDA Device · Class I · 2026-10-21 · Instrumentation Laboratory - HemoslL AcuStar HIT-lgG(PF-4)
FDA Device · Class I · 2026-10-21 · Instrumentation Laboratory - GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 00055430010 00055430011 00055445010 00055445011 00055360…
FDA Device · Class II · 2026-08-12 · Instrumentation Laboratory - GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The G…
FDA Device · Class II · 2026-08-12 · Instrumentation Laboratory - Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Model/Catalog Number: 00024019255 Portable blood analyzer system
FDA Device · Class II · 2026-08-05 · Instrumentation Laboratory
All Instrumentation Laboratory recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0938-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.