Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Fisher Diagnostics · The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Open FDA's page for this record- Cfres ID
- 213023
- Product res number
- Z-1503-2025
- Event date initiated
- 2025-03-06
- Event date posted
- 2025-03-31
- Recall status
- Open, Classified
- Res event number
- 96488
- Product code
- GJS
- Product description
- Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
- Code info
- Catalog No. 100357; UDI: 00845275000798665150270131100357; Lot No. 665150; Exp. Date 01/31/2027.
- Firm FEI number
- 1181121
- Recalling firm
- Fisher Diagnostics
- Address 1
- 8365 Valley Pike
- City
- Middletown
- State
- VA
- Postal code
- 22645-1905
- Additional info contact
- Asiyah Imam 800-528-0494
- Reason for recall
- The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
- Root cause description
- Employee error
- Product quantity
- 1,699 units
- Distribution pattern
- US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
- Action
A "Recall/Field Safety Corrective Action" letter dated 3/5/25 was mailed to consignees instructing them to stop using and discard any affected product in stock, contact their prescribing physicians/Medical Directors for evaluation for further action, and retain a copy of the notification for laboratory records. Consignees are to return the provided Response Form. Consignees with any questions are to contact their Fisher Diagnostic representative or call 800-528-0494. Distributors are to email techsupport.diagnostics.mtn@thermofisher.com with "CDR-FSN-2025-001" in the subject line to coordinate replacements.
- K numbers
- K994100
- Harmonized identifiers (openFDA)
- Device name
- Test, Time, Prothrombin
- Medical specialty description
- Hematology
- Regulation number
- 864.7750
- Device class
- 2
- K number
- K110212, K213426, K992492, K001699, K904454, K780203, K875062, K093243, K872844, K955843, K791022, K994100, K791023, K961835, K151964, K070005, K931118, K012768, K945078, K892050, K132722, K212779, K974343, K843535, K860721, K092940, K253188, K251564, K060931, K122584, K922565, K180693, K792031, K183255, K071041, K092987, K952608, K170960, K884855, K931117 +87 more
- Registration number
- 2085064, 3037000637, 3013298431, 2432235, 9710666, 3005146313, 3008386529, 3002721930, 9610806, 3006198300, 3012302888, 3010285483, 2245578, 8043723, 3015499222, 1835316, 3030186688, 1181121, 3003691680, 1618982, 3025915415, 2245451, 1217183, 3013188547, 9610126, 3011689956, 3013660430, 3007507465, 1219029, 3033967997, 1832816, 3005643513, 2431530
- FEI number
- 3037000637, 3013298431, 2432235, 3005146313, 3008386529, 3006198300, 3003565434, 3012302888, 3010285483, 3002806559, 3001644026, 2245578, 3001573851, 3015499222, 3030186688, 3000210416, 1181121, 3003691680, 1618982, 1000135102, 2250033, 3025915415, 2245451, 1217183, 3013188547, 3011689956, 3013660430, 3007507465, 1219029, 3033967997, 1832816, 3005643513, 2431530