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Diagnostic Chemicals, Ltd.

CanadaFDA applicant, unverified

Devices
66
FDA recalls
6

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue66

Newest first, rows 1-50 of 66

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Rows 1-50 of 66

Showing 1-50 of 66

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

  • 2010

    • 10 Nov 2010 Z-0711-2011 Unclassified (pre-2012) Terminated Cholesterol Reagent bottles labels reversed for R1 and R2 Distribution: Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada. Submission number: K842160

  • 2009

    • 12 Feb 2009 Z-2326-2009 Unclassified (pre-2012) Terminated Labeled with extended expiration date (24 months instead of 18 months) Distribution: Worldwide Distribution -- United States (AL, CA, NJ, MO, PA, KY, FL, LA, MN, NY, NC, OH, TX and UT), Canada and Korea. Submission number: K070383
    • 12 Feb 2009 Z-2327-2009 Unclassified (pre-2012) Terminated Labeled with extended expiration date (24 months instead of 18 months) Distribution: Worldwide Distribution -- United States (AL, CA, NJ, MO, PA, KY, FL, LA, MN, NY, NC, OH, TX and UT), Canada and Korea. Submission number: K070383

  • 2008

    • 14 Mar 2008 Z-1327-2009 Unclassified (pre-2012) Terminated Precipitate in product may cause elevated background absorbance interference. Distribution: Nationwide Distribution Submission number: K961587

  • 2006

    • 5 Dec 2006 Z-0361-2007 Unclassified (pre-2012) Terminated Upon subsequent testing on different instruments (as required by other customers), DCL detected a non-linear response on certain analyzers. A decision was made to recall the product due to the fact that DCL customers sell the product to different end users, DCL cannot be certain which instruments the end users employ in their laboratories Distribution: PA Submission number: K042329
    • 6 Sep 2006 Z-0536-2007 Unclassified (pre-2012) Terminated Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct Distribution: Nationwide. Submission number: K042243

Frequently asked questions

How many devices does Diagnostic Chemicals, Ltd. have in the registry?

The registry currently lists 66 devices for Diagnostic Chemicals, Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Diagnostic Chemicals, Ltd.'s devices?

Among its 50 most recently registered devices, Diagnostic Chemicals, Ltd. has devices listed in FDA 510(k) (50 devices).

What risk classes do Diagnostic Chemicals, Ltd.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Diagnostic Chemicals, Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Diagnostic Chemicals, Ltd.?

FDA recall records list 6 recalls initiated by Diagnostic Chemicals, Ltd., the most recent initiated on 2010-11-10. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Diagnostic Chemicals, Ltd. in the registry?

The most recently registered devices listed for Diagnostic Chemicals, Ltd. include UNSATURATED IRON BINDING CAPACITY (UIBC) ASSAY, CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30, ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30 and HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278.

Generated automatically from registry data and not verified by a human reviewer.