FDA-Device2019-05-29Class II
Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Polymer Technology Systems, Inc.
Hazard
Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Sold states
Domestic distribution nationwide.
Affected count
67643 total
Manufactured in
7736 Zionsville Rd, N/A, Indianapolis, IN, United States
Products
Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1372-2019Don't want to check this manually?
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