Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB)… recallZ-0875-06 · Dade Behring , Inc. · initiated Apr 3, 2006
Terminated All recalls posted in May 2006
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 Dade Behring , 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
Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.
FDA root cause category: Other
What the company is doing
Customers were provided clear written instructions (04/06/2006) to discontinue use and discard remaining inventory of products over 2 months old. In addition, each customer is being contacted by phone as an effectiveness verification. Recalling firm is also instructing Stratus CS customers to process all samples and dilutions in duplicate.
Recall details
- Recall number
- Z-0875-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 3, 2006
- Posted by the FDA
- May 19, 2006
- Recalling firm
- Dade Behring , Inc.
- Quantity
- 3229 cartons of 100 TestPaks
- Product code
- JHX
- FDA submissions
- K984067
- Distribution
- Nationwide to hospitals and government accounts in addition to International accounts in Canada, Saudi Arabia, Bangladesh, UAE, India, Japan, Denmark, and Australia.
Product description
Stratus CS STAT Fluorometric Analyzer CKMB TestPak (CCKMB) in vitro diagnostic.
Code information (models, lots, serial numbers)
Lot #245276002; 245289002; 245304002; 245318002; 245332002; 245361002; 246023002; 246037002; 246051002; 246065002; and 246079002
Other devices under the same FDA submission
1 device cleared under K984067 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Stratus® CS 10444834Siemens Healthcare Diagnostics Inc. · FLUOROMETRIC METHOD, CPK OR ISOENZYMES71 reports
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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