FDA Medical Device Recalls (openFDA)
Instrumentation Laboratory: HemosIL SynthAFax. Partial Thromboplastin Time Tests.
- Recall number
- Z-0938-2026
- Recalling firm
- Instrumentation Laboratory
- Product
- HemosIL SynthAFax. Partial Thromboplastin Time Tests.
- Status
- Open, Classified
- Initiated
- 2025-11-18
- Posted
- 2025-12-17
- Terminated
- not on file
- Reason
- Recalled lots were manufactured with double the amount of preservative concentration.
- Root cause
- Process control
- Action
- An URGENT MEDICAL DEVICE RECALL notification, dated 11/18/25, was sent to consignees. Consignees are to contact Client Services at 1-800-955-9525 to arrange conversion to replacement lot N0956748, and in the meantime continue use of affected lots with the QC lot reassignments provided and run QC per labeled instructions for use. Once the replacement lot is received, consignees are to complete the cross-over study per laboratory procedures and immediately destroy affected devices, documenting destruction on the provided Mandatory Urgent Medical Device Recall Tracking Form which should be returned to WERFEN by fax at 781-861-4207 or by email to ra-usa.na@werfen.com. All laboratory staff are to be notified of this recall and a copy of the notice posted near IL Coagulation Systems. Consignees with any questions are to contact Client Services at 1-800-955-9525.
- Quantity
- 4,506 units
- 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.
- Lot, serial or model codes
- Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30).
- 510(k) numbers
- ["K955638"]
- PMA numbers
- not on file
- Product code
- GFO
- Firm FEI
- 1217183
- Firm city
- Bedford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28