openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 3
Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414
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 displayed.
These labels are deterministic app interpretations, not FDA categories.
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 displayed.
Code information
P832
Distribution pattern
Domestic distribution nationwide.
device · product 2 of 3
Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412
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
These labels are deterministic app interpretations, not FDA categories.
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
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 displayed
These labels are deterministic app interpretations, not FDA categories.
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 displayed
