Abbott CELL-DYN 3500 Hematology Analyzer recallZ-1199-2007 · Abbott Laboratories · initiated May 11, 2007

Terminated All recalls posted in August 2007

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

The product failed electrostatic discharge testing, which could result in product failure.

FDA root cause category: Other

What the company is doing

Mandatory Technical Service Bulletins (TSB) are being issued to Field Service to upgrade all instruments in the field. All customers will be contacted by Field Service to schedule this mandatory upgrade. The upgrades are expected to take 12 months.

Recall details

Recall number: Z-1199-2007
Recall class: Not yet classified by the FDA
Status: Terminated
Initiated by the company: May 11, 2007
Posted by the FDA: Aug 29, 2007
Recalling firm: Abbott Laboratories
Quantity: 3,429 units, all models
Product code: GKZ
FDA submissions: K913305, K955715, K960427, K980614, K991605
Distribution: Worldwide, including USA, Puerto Rico, Canada, Mexico, Argentina, Australia, Bahamas, Brazil, Chile, China, Colombia, Costa Rica, Dominican Republic, El Salvador, Ecuador, Germany, Guatemala, Hong Kong, Jamaica, Japan, New Zealand, Panama, Paraguay, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay, and Venezuela.

Product description

Abbott CELL-DYN 3500 Hematology Analyzer

Code information (models, lots, serial numbers)

Model number CELL-DYN 3500 CS, List Numbers 91340-01 and 91340-03, all serial numbers distributed before May 3, 2007. Model number CELL-DYN 3500 SL, List Numbers 91350-01 and 91350-03, all serial numbers distributed on or before May 3, 2007: 91350-01 1 EACH CD3500 SL ANALYZE(1 EACH) 1.000 0031192P, 91350-03 1 EACH CD3500SL ANAL-REF(1 EACH) 1.000 30336P96, 91350-03 1 EACH CD3500SL ANAL-REF 1.000 32159P96 05/05/2000, 91340-03 1 EACH CD 3300/3500CS(1 EACH) 1.000 30276N96 06/21/2000

Other devices under the same FDA submission

3 devices cleared under K913305, K955715, K960427, K980614, 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 02H31-01
Abbott Laboratories · Counter, differential cell
4 reports
CELL-DYN 02H31-03
Abbott Laboratories · Counter, differential cell
3 reports
CELL-DYN 02H30-01
Abbott Laboratories · Counter, differential cell
2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 38322).

Z-1200-2007 · Terminated
Abbott CELL-DYN 3700 Hematology Analyzer

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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