CLASS III Device recall · Reported 16 Jan 2013 · FDA Enforcement Report
Immunoradiometric assay recalled by Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics is recalling Immunoradiometric assay, distributed in 8 states. The recall was initiated on 28 Nov 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0647-2013
- FDA event ID
- 63852
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Nov 2012
- FDA classified
- 7 Jan 2013
- Reported
- 16 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 28 Nov 2012 | Recall initiated by company | |
| 7 Jan 2013 | Classified by FDA | +40 days |
| 16 Jan 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Immunoradiometric assay.
Where it was distributed
Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,
CaliforniaGeorgiaIllinoisIndianaMichiganMinnesotaNew YorkPuerto Rico
Questions about this recall
Why was it recalled?
The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values with some vials of Coat-A-Consta (CAC) IRMA TSH calibrators TSI4 (level B), TSI5 (level C), TSI6 (level D), TSI8 (level F), and TSI9 (level G) lot 035. The affected calibrator vials can be identified by a darker yellow color than normal. The TSI3 (level A), TSI7 (level E), and TSIX (level H)
Which lots are affected?
Lots 831 and 832
Where was it sold?
Worldwide Distribution - USA including CA, GA, IL, IN, MI, MN, NY, and Puerto Rico. Internationally to Agentina, Bolivia, Brazil, Canada, Chile, Guatemala, South Korea, Philippines, Paraguay, Taiwan, and Uraguay,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 63852This product is part of a recall event; the main page for the event is Immunoradiometric assay recalled by Siemens Healthcare Diagnostics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Immunoradiometric assay recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Potency & Assay | 8 states | |
| CLASS III | Immunoradiometric assay recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Potency & Assay | 8 states |
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