STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
Diagnostica Stago, Inc. · A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Open FDA's page for this record- Cfres ID
- 221774
- Product res number
- Z-3047-2026
- Event date initiated
- 2026-07-29
- Event date posted
- 2026-08-28
- Recall status
- Open, Classified
- Res event number
- 99531
- Product code
- GGP
- Product description
- STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitative and quantitative factor deficiency test
- Code info
- UDI : (01)3607450007466(11)250331(17)270331(10)273074(241)00746, Exp 3/31/2027
- Firm FEI number
- 2245451
- Recalling firm
- Diagnostica Stago, Inc.
- Address 1
- 5 Century Dr
- City
- Parsippany
- State
- NJ
- Postal code
- 07054-4607
- Additional info contact
- Technical Hotline 800-7250607
- Reason for recall
- A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
- Root cause description
- Under Investigation by firm
- Product quantity
- 5220 units
- Distribution pattern
- US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, PR.
- Action
Diagnostica Stago issued an URGENT: MEDICAL DEVICE RECALL (REMOVAL) notice to its consignees on 7/29/2026 via email. The notice described the issue, risk assessment, and requested the following: "Actions Required To prevent potential workflow disruptions associated with the increased recalibration frequency, we request that you: " Immediately discontinue use of STA-Staclot Protein S, Lot 273074. " Dispose of any remaining inventory of the affected lot in accordance with your facility's procedures and local regulations. " Complete, sign, and return the enclosed Acknowledgement Form by email to confirm receipt and understanding of this notification. Stago will provide a credit for the destroyed kits you indicate on the Acknowledgement Form." For questions regarding this notice or require assistance, please contact Stago's 24/7 Hotline at 1-800-725-0607.
- K numbers
- K913424
- Harmonized identifiers (openFDA)
- Device name
- Test, Qualitative And Quantitative Factor Deficiency
- Medical specialty description
- Hematology
- Regulation number
- 864.7290
- Device class
- 2
- K number
- K884797, K050365, K960438, K870354, K834031, K903468, K812431, K823453, K843438, K934584, K961929, K981200, K870917, K882603, K954017, K833892, K062530, K931906, K872479, K924884, K896174, K861475, K955738, K230852, K861217, K884551, K981817, K921449, K002350, K864497, K013168, K033631, K972288, K834051, K951640, K102164, K983898, K812974, K884544, K032139 +150 more
- Registration number
- 3003691680, 3004434070, 1217183, 2518152, 2183608, 8043599, 3004737529, 2245451, 3003485232, 2431530, 9610746, 3037000637, 3008386529, 9710666, 2432235, 9610806, 1618982, 1721937, 3004075036, 1835316, 3003601075
- FEI number
- 3003691680, 3004434070, 1217183, 2518152, 2183608, 3004737529, 2245451, 3003485232, 2431530, 3001644026, 3037000637, 1000117401, 3008386529, 3005917516, 2432235, 3002806557, 1618982, 3000210416, 3003565434, 3004075036, 3003601075