Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103
Accriva Diagnostics, Inc. · Microcoagulation test used to evaluate low dose heparin anticoagulation has a mispositioned or absent clot activating reagent, which may result in out-of-range…
Open FDA's page for this record- Cfres ID
- 222749
- Product res number
- Z-0317-2027
- Event date initiated
- 2026-09-14
- Event date posted
- 2026-10-30
- Recall status
- Open, Classified
- Res event number
- 99863
- Product code
- JPA
- Product description
- Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103
- Code info
- UDI-DI: 10711234103012, Lot(Expiration): B6JCA005(02/28/2027), C6JCA008(03/31/2027), D6JCA011(04/30/2027), K5JCA041(10/31/2026), C6JCA007(03/31/2027)
- Firm FEI number
- 2250033
- Recalling firm
- Accriva Diagnostics, Inc.
- Address 1
- 6260 Sequence Dr
- City
- San Diego
- State
- CA
- Postal code
- 92121-4358
- Additional info contact
- Paula Morgan 858-263-2590
- Root cause description
- Process control
- Product quantity
- 28710
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of MA, MO, AK, WV, NJ, TX, VA, IL, NY and the countries of China, Colombia.
- Reason for recall
Microcoagulation test used to evaluate low dose heparin anticoagulation has a mispositioned or absent clot activating reagent, which may result in out-of-range high error code, or erroneously high results, which may lead retest, or overestimation of patient's anticoagulation, leading to inadequate anticoagulant therapy, which could result in thrombosis.
- Action
On 9/14/2026, recall notices were mailed to customers who were informed of the following: 1) Please forward this communication to those within your organization who need to be aware of this matter and verify they understand the procedure and can complete the enclosed forms. 2) Forward the enclosed customer notification to all other organizations where affected devices may have been transferred to. 3) Please check your inventory and do not use affected lots. 4) Scrap/destroy all impacted cuvettes and/or boxes. 5) Complete and return the Acknowledgement and Receipt Form via email to ilsd_ra.na@werfen.com Questions about receiving credit, should be directed to Customer Service at 1-800-955-9525 or e-mail customerservice.na@werfen.com. Technical questions should be directed to Technical Services at 1-800-678-0710 Option 3 or email techsupport.na@werfen.com.
- K numbers
- K940401
- Harmonized identifiers (openFDA)
- Device name
- System, Multipurpose For In Vitro Coagulation Studies
- Medical specialty description
- Hematology
- Regulation number
- 864.5425
- Device class
- 2
- K number
- K832225, K900506, K170314, K161317, K161312, K093167, K930454, K791586, K960875, K934747, K942096, K860719, K870960, K864534, K761176, K251024, K983460, K173202, K050053, K870831, K870685, K940957, K881367, K051030, K853078, K162688, K970431, K002080, K253658, K000053, K201440, K984501, K030818, K842717, K880713, K883637, K914188, K761173, K853328, K160502 +142 more
- Registration number
- 9610806, 3006198300, 2431530, 2432235, 1644474, 3020704087, 1000340866, 1718389, 3003601075, 3037000637, 9613959, 3019849102, 1220649, 1219738, 8020030, 3008386529, 2184009, 3021389305, 3007701696, 3010960914, 3007507465, 3005792925, 9610746, 3002721930, 3004035727, 3012348571, 3005269352, 8043723, 3009495621, 1618982, 1719400, 3003943960, 3010653929, 2245451, 3009711478, 3015222335, 2026994, 1219343, 1217183, 2132111 +2 more
- FEI number
- 1000116989, 3006198300, 2431530, 1000116158, 2432235, 3001644026, 3020704087, 3006461677, 1000340866, 1718389, 3003601075, 3037000637, 3019849102, 1220649, 1219738, 1000140026, 3001573851, 3002808301, 3002806557, 3008386529, 3021389305, 3007701696, 3010960914, 3007507465, 3005792925, 3012348571, 3004035727, 3005269352, 3009495621, 1618982, 2250033, 1719400, 3003943960, 3010653929, 2245451, 3009711478, 3015222335, 2026994, 1219343, 1217183 +2 more