Diagnostica Stago STA Staclot Protein S Recall Over QC Drift in Lot 273074
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Diagnostica Stago, Inc. is recalling 5,220 units of STA Staclot Protein S reagent lot 273074 due to positive drift in QC values during the 4-hour onboard stability period.
The full picture behind this FDA recall
This notice was issued by FDA on September 14, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified", distributed 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.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
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What Happened
Diagnostica Stago, Inc. initiated a voluntary recall after identifying a positive drift in QC values within the reagent's stated 4-hour onboard stability period.
Which Products Are Affected
The recall affects STA Staclot Protein S, Model/Catalog Number 00746, Reagent Lot number 273074. A total of 5,220 units are involved. The product is labeled with UDI (01)3607450007466(11)250331(17)270331(10)273074(241)00746 and has an expiration date of 3/31/2027. Distribution was nationwide across the United States, including the states and territory of NJ, NY, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, and PR. The recall number is Z-3047-2026 and it is classified as Class II.
What You Should Do
Consumers and facilities should follow the firm's instructions provided via the initial E-Mail notification regarding the affected reagent. Contact Diagnostica Stago, Inc. at 5 Century Dr, Parsippany, NJ 07054-4607 for return or refund information.
Why This Matters
The affected reagent is used for qualitative and quantitative factor deficiency testing, and the identified QC drift may impact test reliability during the stated stability period.
Source
FDA recall number Z-3047-2026; voluntary firm-initiated recall reported to the FDA.
Original source: FDA Official Notice ↗
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