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Greer Laboratories, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 1011574

Devices
2
Registrations
FDA
FDA recalls
3

Catalogue2

Newest first, rows 1-2 of 2

Company details

FDA FEI number
1011574
Address
639 NUWAY CIRCLE, N.E., Lenoir, NC, 28645

FDA recalls3

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

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 2
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

1 initiated before 2017

  • 2022

    • 25 Oct 2022 Z-0347-2023 Class II Terminated The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted. Distribution: US Distribution to states of: CA, CO, IA, KY, MA, MD, MO, NC, PA, UT, VA, and International to countries of: Canada,…
      Full distribution text US Distribution to states of: CA, CO, IA, KY, MA, MD, MO, NC, PA, UT, VA, and International to countries of: Canada, Denmark
    • 25 Oct 2022 Z-0348-2023 Class II Terminated The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result interpretation. The issue was identified by the firm after failing to meet lot requirements for potency. The lot release error was discovered on October 08, 2021, after a failed potency test was determined during 6-month stability evaluation of retention material for the lots. The subsequent manufacturing investigation, which included a review of the lot release potency documentation, found that the initial lot release potency test for the lot was misinterpreted. Distribution: US Distribution to states of: CA, CO, IA, KY, MA, MD, MO, NC, PA, UT, VA, and International to countries of: Canada,…
      Full distribution text US Distribution to states of: CA, CO, IA, KY, MA, MD, MO, NC, PA, UT, VA, and International to countries of: Canada, Denmark

  • 2005

    • 28 Jan 2005 Z-0567-05 Unclassified (pre-2012) Terminated Product may not be sterile. Distribution: AZ, CA, FL, IL,KY, MA,MD, MI, NC, NJ, NM, OH, PA TN, TX, WI, WV, and Ontario Canada.

Frequently asked questions

How many devices does GREER LABORATORIES, INC. have in the registry?

The registry currently lists 2 devices for GREER LABORATORIES, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list GREER LABORATORIES, INC.'s devices?

Among its 2 most recently registered devices, GREER LABORATORIES, INC. has devices listed in FDA 510(k) (2 devices).

What risk classes do GREER LABORATORIES, INC.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for GREER LABORATORIES, INC.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for GREER LABORATORIES, INC.?

FDA recall records list 3 recalls initiated by GREER LABORATORIES, INC., the most recent initiated on 25 Oct 2022. 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 GREER LABORATORIES, INC. in the registry?

The most recently registered devices listed for GREER LABORATORIES, INC. include GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC and GREER DERMAPIK SYSTEM.

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

This is an FDA establishment record. No EUDAMED registration is known for this company.