CELL-DYN 3700 CS and SL, Hematology Analyzer manufactured… recallZ-2351-2010 · Abbott Laboratories · initiated Apr 16, 2010
Terminated All recalls posted in September 2010
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 Abbott Laboratories 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
Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Product Recall letters were sent on 04/16/2010. The letters identified the affected product, explained the reason for recall, the patient impact/user safety, stated the necessary actions, and contact information. Users are to discontinue use until the Waste Chamber(s) have been replaced and follow the instructions in the Hazards section. In addition, appropriate protective equipment needs to be worn along with following their recommended laboratory procedures dealing with spills. Users are to contact their local Abbott Customer Support rep. US customers should be direct their questions to Customer Support.
Recall details
- Recall number
- Z-2351-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 16, 2010
- Posted by the FDA
- Sep 2, 2010
- Recalling firm
- Abbott Laboratories
- Quantity
- 69 units total
- Product code
- GKZ
- FDA submissions
- K991605
- Distribution
- Worldwide Distribution -- CA, CT, ID, IN, and MA; and, countries of Australia, Brazil, Canada, China, Colombia, Mexico, Puerto Rico, Singapore, and Uruguay.
Product description
CELL-DYN 3700 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.
Code information (models, lots, serial numbers)
Reservoir Date Codes Dec 17 2009 to March 17, 2010. Part Number/Serial numbers-- CS: 02H30-01/20478AN, 20479AN SL: 02H31-01/22470AK, 21690AK, 22062AK, 21699AK, 20756AK, 22459AK, 21302AK, 21601AK, 22753AK
Other devices under the same FDA submission
3 devices cleared under K991605 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CELL-DYN 02H31-01Abbott Laboratories · Counter, differential cell4 reports
- CELL-DYN 02H31-03Abbott Laboratories · Counter, differential cell3 reports
- CELL-DYN 02H30-01Abbott Laboratories · Counter, differential cell2 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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