The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1092-2017·Announced 2017-02-01

Roche Tina-Quant CRP Latex Test System Recalled for Low Results

Roche is recalling Tina-Quant CRP Latex High Sensitive test kits due to potential under-recovery of results, which may lead to incorrect cardiovascular risk assessments.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (delayed diagnosis of cardiovascular risk) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling the Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive), catalog number 11972855216, lot number 60445001. The recall involves 3,204 units that were distributed nationwide, including to facilities in Alabama, Arizona, California, Connecticut, Florida, Georgia, Kansas, Massachusetts, Missouri, New Jersey, New York, Pennsylvania, and Washington.

The recall was initiated because the test system shows an under-recovery of up to -25% at concentrations below 5 mg/L when used on the MODULAR ANALYTICS P module. This issue can lead to erroneously low C-reactive protein (CRP) results. Since CRP is used as a marker for the prediction of cardiovascular risk, an erroneous low result could lead to an incorrect cardiovascular risk assessment and a subsequent delay in further examination.

Healthcare facilities and laboratories should stop using the affected lot and contact Roche Diagnostics for instructions on returning the product or obtaining replacements. Consumers should consult their healthcare providers if they have received test results using this specific lot and are concerned about the accuracy of their cardiovascular risk assessment.

The recalled product

Product
Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical…
Manufacturer
Roche Diagnostics Operations, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
3,204

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Catalog number: 11972855216
  • lot number 60445001

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

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