FDA Medical Device Recalls (openFDA)
Instrumentation Laboratory Co.: Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
- Recall number
- Z-0895-2018
- Recalling firm
- Instrumentation Laboratory Co.
- Product
- Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
- Status
- Terminated
- Initiated
- 2017-08-02
- Posted
- 2018-03-03
- Terminated
- 2019-03-29
- Reason
- Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.
- Root cause
- Under Investigation by firm
- Action
- On August 2, 2017, Instrumentation Laboratory sent an Urgent Medical Device Removal letters dated August 2, 2017 to their customers. On October 5, 2017 Instrumentation Laboratory expanded their recall adding 3 additional lots to a second Urgent Medical Device Removal letter. On February 26, 2018, Instrumentation Laboratory expanded their recall a 3rd time to include 1 additional lot to a third Urgent Medical Device Removal letter. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete a Mandatory Tracking Response form. For questions contact your Customer Service Representative at 1-800-955-9525, option #1.
- Quantity
- 14,894 kits
- Distribution
- Worldwide Distribution - US Nationwide
- Lot, serial or model codes
- Lots: N1166235, N0177760, N0278358, N0478057, N0479504 & N0278177.
- 510(k) numbers
- ["K122584"]
- PMA numbers
- not on file
- Product code
- GJS
- Firm FEI
- 1217183
- Firm city
- Bedford
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28