Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL… recallZ-0069-2012 · Siemens Healthcare Diagnostics, Inc. · initiated Aug 31, 2011
Terminated All recalls posted in October 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Firm has confirmed customer complaints for low recovery of QC and patient samples.
FDA root cause category: Process control
What the company is doing
Siemens Healthcare Diagnostics, Inc. Urgent Field Safety Notice was sent to customers on August 31, 2011 regarding the issue. The letter instructs customers to immediately discontinue use of the affected lots and discard all remaining inventory.
Recall details
- Recall number
- Z-0069-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 31, 2011
- Posted by the FDA
- Oct 19, 2011
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 6,072 cartons
- Product code
- JJE
- FDA submissions
- K081643
- Distribution
- Worldwide distribution: USA, Puerto Rico, Guam, Austria, Canada, Croatia, France, Greece, Germany, Italy, Japan, Mexico, Portugal, Spain and Switzerland.
Product description
Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
Code information (models, lots, serial numbers)
Lot Numbers ED2098, EA2111, FB2134, ED2147
Other devices under the same FDA submission
2 devices cleared under K081643 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Dimension® EXL™ LOCI® Module Flex® reagent cartridge TNI 10464525Siemens Healthcare Diagnostics Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT66 reports
- Dimension Vista®/Dimension® EXL™ CTNI SDIL 10445205Siemens Healthcare Diagnostics Inc. · IMMUNOASSAY METHOD, TROPONIN SUBUNIT1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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