Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported January 16, 2013
Immunoradiometric assay.
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics recalled Immunoradiometric assay. - a low-severity action.
Immunoradiometric assay. was recalled by Siemens Healthcare Diagnostics in January 16, 2013. Reason: The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values wi…. Check the official notice for the remedy. Verify recall #Z-0647-2013 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics issued this low-severity FDA Devices recall-The recall was initiated because Siemens Healthcare Diagnostics confirmed an under-recovery of dose values wi….
- Low
- severity level
- Class III
- classification
- January 16, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0647-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0647-2013) was formally reported on January 16, 2013, with the manufacturer initiating the action on November 28, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Siemens Healthcare Diagnostics is listed as the recalling firm, operating out of Tarrytown, NY. Federal records list the affected scope as Lot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees).
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: 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,. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Lot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees)
Related Recalls
6
3 from same agency
Product description
Immunoradiometric assay.
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)
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0647-2013 |
| Date reported | January 16, 2013 |
| Date initiated | November 28, 2012 |
| Recalling firm | Siemens Healthcare Diagnostics |
| Firm location | Tarrytown, NY |
| Affected scope | Lot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees) |
| Distribution | 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, |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0647-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Immunoradiometric assay.. Recalled by Siemens Healthcare Diagnostics. Units affected: Lot 831=19 units (all foreign consignees) and Lot 832=2 units (all foreign consignees).
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on January 16, 2013. Severity: Low. Recall number: Z-0647-2013.
Where was the recalled product distributed? ▼
Distribution: 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,.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0647-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 16, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.